* FDA urged the company to submit their PMA!
* 93% of trial participants still active at 1-year end!
* Fantastic P values over sham(see presentation slide)!
* Only 3% serious adverse events vs. allowable 15%!
* Lap Band affects organ & muscle loss-none with VBLOC!
* Expect additional CE mark in Europe in 2013 for diabetes and hypertension!
* Over 1/3 of patients in the study that got Aussie approval have had the implants at 5 years and some as long as 7 years WITH NO PROBLEMS!
* VBLOC has the potential to reduce or eliminate the need for blood pressure medicine!
* FDA well aware of and concerned about exaggerated placebo effect in trials!
FDA LIKES THE FACT THEY SET STANDARD ENDPOINTS SO HIGH. NO SAFETY ISSUES AND EFF
RATES ALL THE PILL MAKERS WOULD BE JEALOUS OF .......THE FDA will not approve only on obesity
regimen...but data on Diabetes...is EXTREMELY compelling....and the real kicker.
That fact that Knudson said the FDA "urged" the company to file is very telling. The FDA's political agenda includes showing they are serious about advancing treatments that attack obesity and diabetes.
* For those fortunate enough to lose 50% or more VBLOC was 13 times more effective than sham!
* Even if trial participants didn't lose weight with VBLOC, their glucose level WOULD STILL BE IMPROVED!
* FDA is aware and will take into consideration that the sham control group performed four times better than target expectations-a real shock to both the FDA and the company, as this is significantly outside normal placebo effect boundaries!
* The FDA is especially concerned with negative cardiovascular signals, but VBLOC generated heartening POSITIVE cardiovascular signals!
I agree, a solid presentation for device measure of efficacy and safety. Why this product has not had attention yet is beyond me? A clear 1.0% drop A1c from baseline 7.8% is a big deal. I noticed in this and other trials of VBLOC that weigh and A1c and BP continue to reduce AFTER 12 months. Be interested to see what data they have on each additional year of device effects.
I was looking but could not find what the reason(s) were for the 4-5% withdraw rate...any ideas? They did not mention anything significant or serious though...
The withdrawal rate could be non compliant patients who expected weight loss miracles, were lazy about recharging(daily recharge only take 20-30 minutes while one goes about normal activity; battery charge last 3-7 days), moved away. It should be noted that non-charging poses no health risks.